LOADPRO™ Intraoperative Rod Strain Sensor

Intraoperative Orthopedic Strain Sensor

Intellirod Spine, Inc.

The following data is part of a De Novo classification by Intellirod Spine, Inc. with the FDA for Loadpro™ Intraoperative Rod Strain Sensor.

Pre-market Notification Details

DeNovo IDDEN180012
Device Name:LOADPRO™ Intraoperative Rod Strain Sensor
ClassificationIntraoperative Orthopedic Strain Sensor
Applicant Intellirod Spine, Inc. 554f White Pond Drive Akron,  OH  44320
ContactRichard R. Navarro
Product CodeQFP  
CFR Regulation Number888.3090 [🔎]
DecisionGranted (DENG)
Review Advisory BoardOrthopedic
Classification AdvisoryOrthopedic
TypeDirect
Date Received2018-03-14
Decision Date2019-03-28
Reclassification Order:Reclassification Order

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